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FDA 510(k)

THE Graft Collagen

K-Number: K230305 · 2024-07-24

ApplicantPurgo Biologics, Inc.
Decision Date2024-07-24
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE Graft Collagen is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K230305. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE Graft Collagen?

THE Graft Collagen is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K230305.

When did THE Graft Collagen receive FDA 510(k) clearance?

THE Graft Collagen received FDA 510(k) clearance on 2024-07-24, under 510(k) number K230305.

Who is the listed applicant for THE Graft Collagen?

The FDA 510(k) record lists Purgo Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE Graft Collagen?

The FDA product code for THE Graft Collagen is NPM.

Other records listing Purgo Biologics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230091THE CoverK222549OpenTexK191737The Graft Bone SubstituteK180992BiotexK173188The Graft Natural Bone Substitute

Related Devices (Code: NPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK240661Geistlich Bio-Oss®Geistlich Pharma AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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